Adalimumab

Class: Disease-modifying Antirheumatic Agents
VA Class: MS190
Brands: Humira

Special Alerts:

[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNF blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNF blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNF blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: and .

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

• 
  

  Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.

  
  


• 
  

  Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.

  
  


• 
  

  Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

  
  

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for adalimumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of adalimumab and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Serious Infections


• 
  

  Serious, sometimes fatal infections including tuberculosis (frequently disseminated or extrapulmonary), bacterial and viral infections, invasive fungal infections (may be disseminated), and other opportunistic infections reported.¹ (See Infectious Complications under Cautions.)

  
  


• 
  

  Carefully consider risks and benefits prior to initiating adalimumab therapy in patients with chronic or recurring infections.¹

  
  


• 
  

  Evaluate patients for latent tuberculosis infection prior to and periodically during adalimumab therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating adalimumab therapy.¹

  
  


• 
  

  Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.¹ Discontinue adalimumab if serious infection or sepsis occurs.¹ Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.¹

  
  

• Malignancy


• 
  

  Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents.¹ (See Malignancies and Lymphoproliferative Disorders under Cautions.)

  
  

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G₁ (IgG₁) monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-α).¹

Uses for Adalimumab

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Rheumatoid Arthritis in Adults

Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.^{1 3 11} Use alone or in combination with methotrexate or other DMARDs.¹

Juvenile Arthritis

Management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children.^{1 20} Use with or without methotrexate.^{1 20}

Psoriatic Arthritis

Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with psoriatic arthritis.^{1 14 15} Use alone or in combination with other DMARDs.¹

Ankylosing Spondylitis

Management of the signs and symptoms of active ankylosing spondylitis.^{1 16}

Crohn’s Disease

Used to reduce signs and symptoms of Crohn’s disease and to induce and maintain clinical remission in adults with moderately to severely active disease who have had inadequate response to conventional therapy.¹ Also used to reduce signs and symptoms of the disease and to induce clinical remission in adults with moderately to severely active Crohn’s disease who have lost response to or are intolerant to infliximab.¹

Plaque Psoriasis

Management of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and in whom other systemic therapies are medically less appropriate.¹ Use only in patients who will be closely monitored and who will have regular follow-up visits with a clinician.¹

Adalimumab Dosage and Administration

General

Concomitant Therapy

• 
  

  Methotrexate, other DMARDs, corticosteroids, salicylates, NSAIAs, and analgesics may be continued in adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.¹

  
  


• 
  

  Methotrexate, corticosteroids, salicylates, NSAIAs, and analgesics may be continued in pediatric patients with juvenile idiopathic arthritis.¹

  
  


• 
  

  Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., mercaptopurine, azathioprine) may be continued in adults with Crohn’s disease.¹

  
  

REMS Program

• 
  

  FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for adalimumab.²²

  
  

• 
  

  The program consists of a medication guide that must be provided to patients (see Advice to Patients) and a communication plan (letters, education guide) targeting selected groups of clinicians.²² The communication plan is not intended to continue throughout the lifetime of the product.²²

  
  

• 
  

  The goals are to inform patients about the serious risks associated with the drug and to inform clinicians about invasive fungal infections associated with use of TNF blocking agents (see Warnings/Precautions under Cautions).²²

  
  

Administration

Sub-Q Injection

Administer by sub-Q injection every other week or every week.¹

Administer sub-Q injections into thighs or abdomen; do not make abdominal injections within 5.18 cm (2 inches) of the umbilicus.² Rotate injection sites.² Give new injections ≥2.54 cm (1 inch) from an old site; do not make injections into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks.²

Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary.¹ The initial self-administered dose should be made under the supervision of a health-care professional.¹

Dosage

Pediatric Patients

Juvenile Arthritis

Sub-Q

Children 4–17 years of age weighing 15 to <30 kg: 20 mg once every other week.¹

Children 4–17 years of age weighing ≥30 kg: 40 mg once every other week.¹

Adults

Rheumatoid Arthritis

Sub-Q

40 mg once every other week.¹

Patients not receiving methotrexate may obtain additional benefit from once weekly doses of 40 mg.¹

Psoriatic Arthritis

Sub-Q

40 mg once every other week.¹

Ankylosing Spondylitis

Sub-Q

40 mg once every other week.¹

Crohn’s Disease

Sub-Q

160 mg once on day 1 (as four 40-mg injections in one day or as two 40-mg injections per day for two consecutive days), followed by 80 mg once 2 weeks later (on day 15).¹ Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose).¹

Plaque Psoriasis

Sub-Q

Initially, 80 mg followed by 40 mg once every other week (maintenance dosage) starting 1 week after the initial dose.¹

Prescribing Limits

Adults

Crohn’s Disease

Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.¹

Plaque Psoriasis

Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.¹

Cautions for Adalimumab

Contraindications

• 
  

  Known hypersensitivity to adalimumab or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Infectious Complications

Serious, sometimes fatal infections (including bacterial, mycobacterial, invasive fungal, viral, and other opportunistic infections) reported with adalimumab or other TNF blocking agents, particularly in patients receiving concomitant therapy with other immunosuppressive agents (e.g., methotrexate, corticosteroids).^{1 19} The most common opportunistic infections include tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis.¹ Infections frequently are disseminated.¹

Do not initiate adalimumab in patients with active infections, including localized infections.¹ Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic or recurring infections, patients with underlying conditions that may predispose them to infections, and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, and blastomycosis are endemic.¹

Closely monitor patients during and after adalimumab therapy for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).^{1 19}

If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.^{1 19} Discontinue adalimumab if serious infection or sepsis develops.^{1 19}

Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.¹ When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to adalimumab therapy.¹ Also consider antimycobacterial therapy prior to adalimumab therapy for individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed and for individuals with a negative tuberculin skin test who have risk factors for tuberculosis.¹ Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.¹

Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.¹ Strongly consider tuberculosis in patients who develop new infections while receiving adalimumab, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.¹

Invasive fungal infections often not recognized in patients receiving TNF blocking agents; this has led to delays in appropriate treatment.¹⁹

Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.^{1 19} Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.^{1 19}

When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.¹⁹ Whenever feasible, consult specialist in fungal infections.¹⁹

Increased incidence of serious infection and neutropenia observed with concomitant use of etanercept (another TNF blocking agent) and anakinra (a human interleukin-1 receptor antagonist).^{1 10} Similar toxicities expected with use of anakinra and other agents that block TNF, including adalimumab.¹ (See Specific Drugs under Interactions.)

Increased incidence of infection and serious infection reported with concomitant use of a TNF blocking agent and abatacept.¹⁷ (See Specific Drugs under Interactions.)

Hepatitis B Virus (HBV) Reactivation

Increased risk of reactivation of HBV infection in patients who are chronic carriers of the virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).¹ Use of multiple immunosuppressive agents may contribute to HBV reactivation.¹

Screen at-risk patients prior to initiation of therapy.¹ Evaluate and monitor HBV carriers before, during, and for up to several months after therapy.¹ Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established.¹ Discontinue adalimumab and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.¹ Not known whether adalimumab can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.¹

Malignancies and Lymphoproliferative Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.^{1 18} Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin’s disease, non-Hodgkin’s lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).^{1 18} Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.¹ FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.¹⁸

In controlled studies, lymphoma was reported more frequently in patients receiving adalimumab or other TNF blocking agents than in control patients.¹ Patients with rheumatoid arthritis, especially those with highly active disease, may be at increased risk of lymphoma.¹

Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.^{1 18} Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.¹⁸ FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.^{1 18}

Other malignancies (e.g., breast, colorectal, lung, prostate, melanoma, nonmelanoma skin cancer) have occurred in patients receiving adalimumab.¹

Role of TNF blocking agents in development of malignancies not fully determined.^{1 18}

Some immune-related diseases (e.g., Crohn’s disease) have been shown to increase risk of cancer independent of treatment with TNF blocking agents, while for others (e.g., juvenile idiopathic arthritis) it is unknown whether there is an increased risk of cancer.¹⁸

Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.¹⁸

Nervous System Effects

Exacerbation of clinical manifestations and/or radiographic evidence of demyelinating disorders, including multiple sclerosis, reported rarely in patients receiving adalimumab or other TNF blocking agents.¹

Exercise caution when considering adalimumab therapy in patients with preexisting or recent-onset CNS demyelinating disorders.¹

Hematologic Effects

Possible pancytopenia (including aplastic anemia), leukopenia, or thrombocytopenia.¹ Consider discontinuance in patients with confirmed hematologic abnormalities.¹

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis reported rarely.¹ Other allergic reactions (e.g., allergic rash, anaphylactoid reactions, fixed drug eruption, nonspecified drug reaction, urticaria) also observed.¹

If serious allergic reaction or anaphylaxis occurs, immediately discontinue adalimumab and initiate appropriate therapy.¹

Latex Sensitivity

The needle cover of prefilled syringes of adalimumab contains dry natural rubber (latex) and should not be handled by individuals sensitive to latex.¹

General Precautions

Cardiovascular Effects

Worsening CHF and new-onset CHF reported in patients receiving adalimumab or other TNF blocking agents.¹ Use with caution and carefully monitor patients with heart failure.¹

Immunologic Reactions and Antibody Formation

Possible formation of autoimmune antibodies.¹ Lupus-like syndrome reported.¹ If manifestations suggestive of lupus-like syndrome develop, discontinue adalimumab.¹

Antibodies to adalimumab may develop.¹ Long-term immunogenicity remains to be determined.¹

Immunosuppression

No evidence of depression of delayed-type hypersensitivity, decrease in immunoglobulin concentrations, or change in the enumeration of effector cell populations, monocytes/macrophages, or neutrophils observed.¹

Safety and efficacy in patients with immunosuppression not evaluated.¹

Immunization

Patients may receive inactivated vaccines.¹ Avoid live vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, smallpox vaccine, typhoid vaccine live oral, varicella virus vaccine live, yellow fever vaccine).¹ (See Interactions.)

Psoriasis

New-onset psoriasis, including pustular and palmoplantar psoriasis, reported with TNF blocking agents, including adalimumab.^{1 18} Onset observed weeks to years following initiation of drug.¹⁸ Some patients required hospitalization.¹⁸ Most patients experienced improvement following discontinuance of the TNF blocking agent.¹⁸ FDA has concluded that there is a possible association between use of TNF blocking agents and development of psoriasis.¹⁸

Exacerbation of existing psoriasis also reported.¹

Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.¹⁸

Specific Populations

Pregnancy

Category B.¹

Pregnancy registry at 877-311-8972.¹

Lactation

Not known whether adalimumab is distributed into milk or is absorbed systemically following ingestion.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy for uses other than juvenile idiopathic arthritis not established in pediatric patients.^{1 9}

Safety and efficacy for the management of juvenile idiopathic arthritis established in pediatric patients 4–17 years of age.¹ Not studied in children <4 years of age; data in patients weighing <15 kg limited.¹

Review vaccination status of the child and administer all age-appropriate vaccines, if possible, prior to initiation of adalimumab.¹

Malignancies, some fatal, reported in children and adolescents who received TNF blocking agents.^{1 18} (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Geriatric Use

No substantial differences in efficacy relative to younger adults.¹

The incidence of serious infection and malignancy in adalimumab-treated patients >65 years of age is higher than the incidence in younger adults.¹ The overall incidence of infection and malignancy is higher in the geriatric population in general than in younger adults; use with caution.¹

Common Adverse Effects

Adults: Upper respiratory tract infection, injection site pain, headache, rash, sinusitis.¹

Pediatric patients 4–17 years of age: Infection, injection site pain, injection site reaction, hypersensitivity reaction (e.g., localized allergic sensitivity reaction, rash), increased CPK concentration.¹

Interactions for Adalimumab

Administered concomitantly with aminosalicylates, methotrexate, other DMARDs, corticosteroids, other immunomodulatory agents, and/or NSAIAs in clinical studies.¹

Vaccines

Patients may receive inactivated vaccines.¹

Avoid live vaccines.¹ No data available on secondary transmission of infection by live vaccines in adalimumab-treated patients.¹

Specific Drugs

Drug	Interaction	Comments
Abatacept	Increased incidence of infection and serious infection, without additional clinical benefit, reported with abatacept and TNF blocking agents in rheumatoid arthritis17	Concomitant use not recommended17
Anakinra	Increased incidence of serious infections and increased risk of neutropenia, without additional clinical benefit, reported with anakinra and etanercept (another TNF blocking agent) in rheumatoid arthritis;1 10 similar toxicities expected with adalimumab and anakinra1	Concomitant use not recommended1
Influenza virus vaccine inactivated	Antibody titers in adalimumab-treated rheumatoid arthritis patients were protective, albeit lower than in placebo-treated patients1
Methotrexate	Decreased adalimumab clearance1	Dosage adjustment not needed1
Pneumococcal polysaccharide vaccine	No difference in antibody response between adalimumab- and placebo-treated rheumatoid arthritis patients1

Adalimumab Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 64%.¹ Peak serum concentrations achieved in 131 hours.¹

Distribution

Extent

Distributed into synovial fluid.¹

Not known whether adalimumab is distributed into milk.¹

Elimination

Metabolism

Metabolic fate undetermined.¹

Elimination Route

Unknown.¹

Half-life

2 weeks (range: 10–20 days).¹

Special Populations

In patients with adalimumab antibodies, clearance of adalimumab is higher.¹

Clearance of adalimumab is lower with increasing age in patients 40–>75 years of age.¹

Stability

Storage

Parenteral

Injection

2–8°C.¹ Do not freeze.¹ Protect from light; store in original carton until time of administration.¹

Actions

• 
  

  Potent antagonist of TNF biologic activity.^{1 3 8}

  
  


• 
  

  Has high specificity and affinity for TNF (TNF-α); does not bind to or inactivate lymphotoxin α (TNF-β).^{1 3 8} Prevents the binding of TNF to cell surface TNF receptors, thereby blocking the biologic activity of TNF.^{1 3 8}

  
  


• 
  

  An immunoglobulin G₁ (IgG₁) made by phage display technology with amino acid sequences from the human germline; does not contain nonhuman components or artificially fused human peptide sequences.^{3 8} Indistinguishable in structure and function from naturally occurring human IgG.^{3 8}

  
  


• 
  

  Produced by recombinant DNA technology in a mammalian cell expression system; purified by a process that includes specific viral inactivation and removal steps.¹

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  A copy of the manufacturer’s patient information (medication guide) for adalimumab must be provided to all patients with each prescription of the drug. (See REMS Program under Dosage and Administration.)^{1 18} Advise patients about potential benefits and risks of adalimumab.^{1 18}

  
  


• 
  

  If the patient or caregiver is to administer adalimumab, provide careful instructions regarding proper dosage and administration of adalimumab, including proper aseptic technique, and proper disposal of needles and syringes.^{1 2}

  
  


• 
  

  Importance of advising patients to seek immediate medical attention if signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) develop.¹

  
  


• 
  

  Risk of lymphoma, leukemia, or other malignancies with TNF blocking agents.^{1 18} Importance of informing patients and families about the increased risk of cancer development in children and adolescents, taking into account the clinical utility of TNF blocking agents, the benefits and risks of other immunosuppressive drugs, and the risks associated with untreated disease.^{1 18} Importance of promptly informing clinicians if signs and symptoms of cancer occur (e.g., unexplained weight loss; fatigue; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding).¹⁸

  
  


• 
  

  Risk of new-onset psoriasis or worsening of existing psoriasis with TNF blocking agents.^{1 18} Importance of informing clinicians of any manifestations of new or worsening psoriasis (e.g., new rash).^{1 18}

  
  


• 
  

  Importance of alerting clinician if allergy to latex exists.^{1 2}

  
  


• 
  

  Importance of taking the drug as prescribed and of not altering or discontinuing therapy without first consulting with a clinician.¹⁸

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and other illnesses (e.g., concomitant or recurrent infections, history of tuberculosis, history of HBV infection).^{1 2 19}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Adalimumab

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	20 mg/0.4 mL	Humira (preservative-free; available as disposable prefilled syringes)	Abbott
		40 mg/0.8 mL	Humira (preservative-free; available as disposable prefilled syringes and as prefilled injection pen)	Abbott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Humira 20MG/0.4ML Kit (ABBOTT): 2/$2,029.90 or 6/$5,821.23

Humira 40MG/0.8ML Kit (ABBOTT): 2/$1,947.08 or 4/$3,851.13

Humira Pen 40MG/0.8ML Kit (ABBOTT): 2/$1,946.00 or 4/$3,828.76

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Abbott Laboratories. Humira (adalimumab) injection prescribing information. North Chicago, IL; 2009 Nov.

2. Abbott Laboratories. Humira (adalimumab) patient information. North Chicago, IL; 2006 Nov.

3. Weinblatt ME. Keystone EC, Furst DE et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate. The ARMADA trial. Arthritis Rheum. 2003; 48:35-45. [IDIS 492001] [PubMed 12528101]

4. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]

5. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. [PubMed 8507213]

6. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. [IDIS 411264] [PubMed 9751088]

7. Sharp JT. Scoring radiographic abnormalities in rheumatoid arthritis. Radiol Clin North Am. 1996; 34:233-41. [PubMed 8633113]

8. Rau R. Adalimumab (a fully human anti-tumor necrosis factor α monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials. Ann Rheum Dis. 2002; 61(Suppl II):ii70-3. [IDIS 489164] [PubMed 12379628]

9. Abbott Laboratories, Abbott Park, IL: Personal communication.

10. Amgen/Wyeth Corporation. Embrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2004 Sep 27.

11. Keystone EC, Kavanaugh AF, Sharp JT et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004; 50:1400-11. [IDIS 516423] [PubMed 15146409]

12. Weinblatt ME, Keystone EC, Furst DE et al. Long-term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4-year extended study. Ann Rheum Dis. 2005 Dec 1 (Epub ahead of print)

13. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Crus B et al. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005; 3: CD005113.

14. Mease PJ, Gladman DD, Ritchlin CT et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005; 52:3279-89. [IDIS 543446] [PubMed 16200601]

15. Gladman DD, Mease PJ, Cifaldi MA et al. Adalimumab improves joint- and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2006 Nov 9. Epub

16. van der Heijde D, Kivitz A, Schiff MH et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006; 54:2136-46. [PubMed 16802350]

17. Bristol-Myers Squibb. Orencia (abatacept) prescribing information. Princeton, NJ; 2009 Aug.

18. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert. Rockville MD; 2009 Aug 4. Available from FDA website. Accessed 2009 Nov 3.

19. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Oct 20.

20. Lovell DJ, Ruperto N, Goodman S et al.. Adalimumab with or without methotrexate in αjuvenile rheumatoid arthritis. N Engl J Med. 2008; 359:810-20. [PubMed 18716298]

21. Targan SR, Hanauer SB, Van Deventer SJH. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn’s disease. N Engl J Med. 1997; 337:1029-35. [IDIS 393095] [PubMed 9321530]

22. Humira (adalimumab) risk evaluation and mitigation strategy (REMS). From FDA website (http: / / www.fda.gov / downloads / Drugs / DrugSafety / PostmarketDrugSafetyInformationforPatientsandProviders / UCM224377.pdf). Accessed 2010 Oct. 15.

More Adalimumab resources

• Adalimumab Side Effects (in more detail)
• Adalimumab Use in Pregnancy & Breastfeeding
• Adalimumab Drug Interactions
• Adalimumab Support Group
• 89 Reviews for Adalimumab - Add your own review/rating

• Adalimumab MedFacts Consumer Leaflet (Wolters Kluwer)


• Adalimumab Professional Patient Advice (Wolters Kluwer)


• adalimumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Humira Prescribing Information (FDA)


• Humira Consumer Overview

Compare Adalimumab with other medications

• Ankylosing Spondylitis
• Behcet's Disease
• Crohn's Disease
• Crohn's Disease, Acute
• Crohn's Disease, Maintenance
• Juvenile Idiopathic Arthritis
• Psoriasis
• Psoriatic Arthritis
• Reiter's Syndrome
• Rheumatoid Arthritis

indinavir

in-DIN-a-vir

Commonly used brand name(s)

In the U.S.

• Crixivan

Available Dosage Forms:

• Capsule

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For indinavir

Indinavir is used alone or in combination with other anti-HIV medicines to treat infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Indinavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Indinavir will not keep you from spreading HIV to other people. People who receive indinavir may continue to have other problems usually related to AIDS or HIV disease.

indinavir is available only with your doctor's prescription.

Before Using indinavir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For indinavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to indinavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of indinavir in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indinavir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving indinavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking indinavir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using indinavir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Alprazolam


• Amiodarone


• Astemizole


• Cisapride


• Colchicine


• Conivaptan


• Dihydroergotamine


• Dronedarone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Methylergonovine


• Midazolam


• Pimozide


• Ranolazine


• Sildenafil


• Silodosin


• Simvastatin


• Terfenadine


• Tolvaptan


• Triazolam

Using indinavir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone


• Atazanavir


• Brentuximab Vedotin


• Cabazitaxel


• Cerivastatin


• Clozapine


• Crizotinib


• Dasatinib


• Docetaxel


• Etravirine


• Everolimus


• Fluticasone


• Garlic


• Iloperidone


• Ixabepilone


• Lapatinib


• Lovastatin


• Nilotinib


• Omeprazole


• Oxycodone


• Pazopanib


• Rifabutin


• Rifampin


• Rifapentine


• Romidepsin


• Rosuvastatin


• Ruxolitinib


• Salmeterol


• St John's Wort


• Sunitinib


• Tadalafil


• Tamsulosin


• Temsirolimus


• Ticagrelor


• Tipranavir


• Toremifene


• Vemurafenib

Using indinavir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine


• Amprenavir


• Ascorbic Acid


• Atorvastatin


• Atovaquone


• Carbamazepine


• Clarithromycin


• Clevidipine


• Cyclosporine


• Dalfopristin


• Darunavir


• Delavirdine


• Didanosine


• Diltiazem


• Efavirenz


• Felodipine


• Fentanyl


• Isradipine


• Itraconazole


• Ketoconazole


• Levodopa


• Nevirapine


• Nicardipine


• Nifedipine


• Nimodipine


• Nisoldipine


• Quinupristin


• Ritonavir


• Saquinavir


• Trazodone


• Vardenafil


• Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of indinavir. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or


• Hemolytic anemia (a blood disorder) or


• Hemophilia (a bleeding disorder) or


• Hepatitis or


• Hyperbilirubinemia (high bilirubin in the blood) or


• Hyperglycemia (high blood sugar) or


• Nephrolithiasis (kidney stones)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of indinavir

Take indinavir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking indinavir without checking first with your doctor.

Indinavir is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment. Your dose of indinavir may depend on the other medicines you are using.

indinavir should be taken with water on an empty stomach (1 hour before or 2 hours after a meal) or with a light meal. Indinavir may also be taken with other liquids (e.g., skim milk, juice, coffee, or tea) or with a light meal (e.g., dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar).

While you are taking indinavir, it is important that you drink extra fluids so that you will pass more urine. This will help prevent possible kidney stones. Follow your doctor's instructions carefully about how much fluid to drink. Usually you will need to drink at least 48 ounces (1.5 liters or 6 full glasses) of fluids every day during your treatment.

Keep taking indinavir for the full time of treatment, even if you begin to feel better.

indinavir works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.

indinavir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

If you miss a dose or forget to use your medicine less than 2 hours, use it as soon as you can. If your next regular dose is more than 2 hours, wait until then to use the medicine and skip the missed dose.

Dosing

The dose of indinavir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of indinavir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For treatment of HIV infection:
    
    • Adults—800 milligrams (mg) every 8 hours. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Indinavir capsules are very sensitive to moisture. Keep them in their original container and leave the drying packet in the container.

Precautions While Using indinavir

It is very important that your doctor check your progress at regular visits to make sure that indinavir is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not take any other medicines without checking first with your doctor. To do so may increase the chance of side effects from indinavir or other medicines.

You should not use indinavir if you are also using medicine for heart rhythm problems (e.g., amiodarone, Cordarone®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergotrate®, Methergine®, Migranal®, or Wigraine®), medicine to lower cholesterol (e.g., lovastatin, simvastatin, rosuvastatin, Crestor®, Mevacor®, or Zocor®), alfuzosin (Uroxatral®), alprazolam (Xanax®), astemizole (Hismanal®), atazanavir (Reyataz®), cisapride (Propulsid®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®), St. John's wort, or triazolam (Halcion®). Using any of them together with indinavir may increase the chance of serious side effects.

indinavir will not protect you from getting HIV/AIDS or other sexually transmitted diseases. Also, it will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

indinavir may raise your blood sugar. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

indinavir may increase your risk of having kidney stones. Check with your doctor right away and stop using indinavir if you have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.

indinavir may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

indinavir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blood in the urine


• sharp back pain just below the ribs

Less common

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• dizziness


• fever


• headache


• itching


• loss of appetite


• nausea


• rash


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Rare

• Confusion


• dehydration


• dry or itchy skin


• fruity mouth odor


• increased hunger


• increased thirst


• increased urination


• pale skin


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in sense of taste


• diarrhea


• difficulty with sleeping


• generalized weakness

Less common

• Acid regurgitation


• acid or sour stomach


• increase in appetite


• belching


• cough


• general feeling of discomfort or illness


• heartburn


• indigestion


• sleepiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: indinavir side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More indinavir resources

• Indinavir Side Effects (in more detail)
• Indinavir Dosage
• Indinavir Use in Pregnancy & Breastfeeding
• Indinavir Drug Interactions
• Indinavir Support Group
• 0 Reviews for Indinavir - Add your own review/rating

• indinavir Concise Consumer Information (Cerner Multum)


• Indinavir MedFacts Consumer Leaflet (Wolters Kluwer)


• Crixivan Prescribing Information (FDA)


• Crixivan Monograph (AHFS DI)

Compare indinavir with other medications

• HIV Infection
• Nonoccupational Exposure
• Occupational Exposure

AstrinGyn

Dosage Form: topical solution
AstrinGyn

AstrinGyn®

(Ferric Subsulfate, Aqueous)

REF 6065

CONTENTS

Ferric subsulfate 259mg/g. Preserved with benzalkonium chloride 0.005%. Povidone USP 23.2%. Glycerin USP 13.3%. Purified Water USP.

DESCRIPTION

AstrinGyn® (Ferric Subsulfate, Aqueous).

HOW SUPPLIED

8 gm single-use glass bottles.

ACTIONS & USES

AstrinGyn® is a styptic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 One method for applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edges of the wound and stretching the skin. The wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.2 

WARNINGS

For External Use Only. Should inadvertent ocular administration occur, the eye(s) should be washed immediately with large amounts of water or normal saline, occasionally lifting the upper and lower lids until no evidence of solution remains (approximately 15-20 minutes).

PRECAUTIONS

As with all iron solutions applied to dermal surfaces denuded of epithelium or to mucous membranes, topical application of AstrinGyn® (ferric subsulfate) may result in hyperpigmentation (“tattooing”).3, 4

Microscopically, this hyperpigmentation may be observed as ferrugination of collagen fibers and fibrin.5  In one study of uterine cervical tissue, ferric subsulfate solution penetrated denuded mucosa and produced coagulation necrosis to a maximum depth of 0.6 mm.6  In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium.7  Should a re-biopsy of the same lesion be required, pathologists and other physicians involved in the care of the patient should be aware of the previous use of ferric subsulfate solution. Previous use of ferric subsulfate solution may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosiderin, together with shrinkage and discoloration of collagen bundles.8, 9   Similarly, previous use of ferric subsulfate solution may result in a radiographic artifact.

CAUTION

Federal law (USA) prohibits dispensing without a prescription.

STORAGE

Keep tightly closed and protect from light.  DO NOT use if seal is broken.  Store at room temperature 59°-86°F (15°-30° C).

DISPOSAL

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for later disposal according to local hazardous waste practices. Waste containing AstrinGyn® should not be subjected to any thermal process whether intended for destruction or recycling purposes.

REFERENCES

1. Armstrong RB, Nichols J. Pachance J. Punch biopsy wounds treated with Monsel’s solution or a collagen matrix. A comparison of healing. Arch. Dermatol 1986;122:546-549.
   


2. Baden HP, Rapid hemostasis with Monsel’s solution (letter). Arch Dermatol 1984; 120:708.
   


3. Demis DJ, Clinical dermatology, Hagerstown MD: Harper & Row, 1986; pp. 11-4:1-11-4:5.
   


4. Camisa C, Roberts W. Monsel solution tattooing (letter). J Am Acad Dermatol 1983;8:753-754.
   


5. Amazon K, Robinson MJ, Rywlin AM. Ferrugination caused by Monsel’s solution. Clinical observations and experimentation. Am J Dermatopathol 1980;2:197-205.
   


6. Davis JR, Steinbronn KK, Graham AR, Dawson BV. Effects of Monsel’s solution in uterine cervix, AM J Clin Pathol 1984;82:332-335.
   


7. Horn MS, Circeo RB, Hassan C. Radiographic artifacts produced by silver nitrate and Monsel’s solution (letter). J Am Acad Dernatol 1983;8:560-562.
   


8. Olmstead PM, Lund HZ, Leonard DD. Monsel’s solution: a histologic nuisance. J Am Acad Dermatol 1980;3:492-498.
   


9. Wood C, Severin GL. Unusual histiocytic reaction to Monsel’s solution. Am J Dermatopathol 1980;2:261-264.

PRINCIPAL DISPLAY PANEL

AstrinGyn ®

Ferric Subsulfate, Aqueous

Contents

One Dozen (12)

8 gm Vials

NDC 59365-6065-1

FERRIC SUBSULFATE  ferric subsulfate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59365-6065 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC SUBSULFATE (FERRIC SUBSULFATE) FERRIC SUBSULFATE 259 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   POVIDONE   GLYCERIN   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59365-6065-1 12 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 8 g In 1 VIAL, SINGLE-USE This package is contained within the CARTON (59365-6065-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/01/1992

Labeler - CooperSurgical, Inc. (801895244)

Revised: 11/2009CooperSurgical, Inc.

More AstrinGyn resources

• AstrinGyn Support Group
• 0 Reviews · Be the first to review/rate this drug

Trihexyphenidyl

Pronunciation: try-hex-ee-FEN-i-dill
Generic Name: Trihexyphenidyl
Brand Name: Generic only. No brands available.

Trihexyphenidyl is used for:

Treating Parkinson disease and other Parkinson-like disorders when used in combination with other medicines. It is used to treat Parkinson-like side effects (eg, involuntary movements) of certain medicines. It may also be used for other conditions as determined by your doctor.

Trihexyphenidyl is an anticholinergic. It works by blocking certain nerve impulses and relaxing certain muscles.

Do NOT use Trihexyphenidyl if:

• you are allergic to any ingredient in Trihexyphenidyl


• you have angle-closure glaucoma, narrowing of the esophagus, stomach or bowel problems (eg, blockage, ulcerative colitis), heart problems due to bleeding, myasthenia gravis, or urinary blockage

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trihexyphenidyl:

Some medical conditions may interact with Trihexyphenidyl. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have high blood pressure, liver or kidney problems, heart problems (eg, irregular heartbeat), blood vessel problems (eg, narrowing), prostate problems, or difficulty urinating


• if you have a history of involuntary movements of the face, tongue, lips, trunk, or extremities


• if you have open-angle glaucoma or you are at risk for glaucoma

Some MEDICINES MAY INTERACT with Trihexyphenidyl. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased or toxic effects increased by Trihexyphenidyl

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trihexyphenidyl may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trihexyphenidyl:

Use Trihexyphenidyl as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Trihexyphenidyl by mouth before or after meals.


• If Trihexyphenidyl tends to dry your mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, thirst can be improved by sucking hard sugarless candy, chewing gum, or drinking water.


• If you miss a dose of Trihexyphenidyl, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Trihexyphenidyl.

Important safety information:

• Trihexyphenidyl may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Trihexyphenidyl with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Trihexyphenidyl may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Lab tests, including eye exams, may be performed while you use Trihexyphenidyl. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Trihexyphenidyl with caution in the ELDERLY, especially patients who may be constipated; they may be more sensitive to its effects.


• Trihexyphenidyl should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trihexyphenidyl while you are pregnant. It is not known if Trihexyphenidyl is found in breast milk. If you are or will be breast-feeding while you use Trihexyphenidyl, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trihexyphenidyl:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; increased sensitivity of the eyes to light; lightheadedness; loss of appetite; nausea; nervousness; trembling of the hands; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; confusion; delusions; difficult swallowing; difficult urination; facial pain or swelling; fast or pounding heartbeat; fever or chills; hallucinations; mood or mental changes; severe constipation; swollen throat glands; uncontrolled movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Trihexyphenidyl side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include depression; difficulty breathing; dilated or sluggish pupils; dry skin; fast breathing; fast heartbeat; high blood pressure; hot, dry, flushed skin.

Proper storage of Trihexyphenidyl:

Store Trihexyphenidyl at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trihexyphenidyl out of the reach of children and away from pets.

General information:

• If you have any questions about Trihexyphenidyl, please talk with your doctor, pharmacist, or other health care provider.


• Trihexyphenidyl is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trihexyphenidyl. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trihexyphenidyl resources

• Trihexyphenidyl Side Effects (in more detail)
• Trihexyphenidyl Dosage
• Trihexyphenidyl Use in Pregnancy & Breastfeeding
• Drug Images
• Trihexyphenidyl Drug Interactions
• Trihexyphenidyl Support Group
• 4 Reviews for Trihexyphenidyl - Add your own review/rating

• Trihexyphenidyl Prescribing Information (FDA)


• trihexyphenidyl Concise Consumer Information (Cerner Multum)


• trihexyphenidyl Advanced Consumer (Micromedex) - Includes Dosage Information


• Trihexyphenidyl Hydrochloride Monograph (AHFS DI)

Compare Trihexyphenidyl with other medications

• Cerebral Spasticity
• Extrapyramidal Reaction
• Parkinson's Disease

Sudodrin

Generic Name: pseudoephedrine (SOO doe ee FED rin)

Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, Nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed

What is Sudodrin (pseudoephedrine)?

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sudodrin (pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Sudodrin (pseudoephedrine)?

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Sudodrin (pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one. Do not take pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since pseudoephedrine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Sudodrin (pseudoephedrine)?

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

Sudodrin (pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness or anxiety;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

  
  

Less serious side effects may include:

• 
  

  loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sudodrin (pseudoephedrine)?

Tell your doctor about all other medicines you use, especially:

• 
  

  blood pressure medications;

  
  


• 
  

  a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sudodrin resources

• Sudodrin Side Effects (in more detail)
• Sudodrin Use in Pregnancy & Breastfeeding
• Sudodrin Drug Interactions
• Sudodrin Support Group
• 0 Reviews for Sudodrin - Add your own review/rating

• Pseudoephedrine MedFacts Consumer Leaflet (Wolters Kluwer)


• Pseudoephedrine Monograph (AHFS DI)


• Cenafed Advanced Consumer (Micromedex) - Includes Dosage Information


• Dimetapp Decongestant Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Drixoral Non-Drowsy Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex Consumer Overview


• Sudafed Consumer Overview


• Tylenol Simply Stuffy Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sudodrin with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about pseudoephedrine.

See also: Sudodrin side effects (in more detail)